Drug product
Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-122-28.
D-0239-2018
Product summary
- Event
- Event 78822
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23,088,900 tablets
- Official record key
drug-enforcement:D-0239-2018
Official wording
Reason: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Code information: Lot #: HN6004, HN6005, HN6006, HN6007, HN6008, HN6009, HN6010, HN6011, HN6012, HN6013, HN6014, Exp 03/18; HN6015, HN6016, HN6017, HN6018, HN6019, HN6020, HN6021, HN6022, HN6023, Exp 04/18; HN6024, Exp 07/18; HN6025, HN6026, HN6027, Exp 09/18
Distribution pattern: Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations